FDA recognizes that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products and lead to difficulties in meeting protocol-specified procedures. Further, FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures.
To provide timely guidance to support continuity and response efforts to this public health emergency, FDA published Guidance on Conducting Clinical Trials of Medical Products during the COVID-19 Public Health Emergency. Although the necessity for, and the impact of, COVID-19 control measures on trials will vary depending on various factors, the guidance provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.
Speakers will include Jacqueline Corrigan-Curay, MD, JD, and John Concato, MD, MS, MPH, of the FDA's Center for Drug Evaluation and Research.
After this webinar, participants will be able to:
* Describe general challenges during the COVID-19 public health emergency that can impact the conduct of clinical trials of medical products.
* Identify key factors that should be considered when sponsors decide whether to suspend or continue an ongoing study, or to initiate a new study, during the COVID-19 public health emergency.
* Identify key factors that should be considered when sponsors decide whether to modify an ongoing study.
* Identify steps to help protocol deviations and amendments that result from challenges related to the COVID-19 public health emergency.